den fikk ett raskt fall ja men tok seg greit inn igjen kun kort tid etter 
1 Like
får bare minne deg om denne @anon80503862
Sussanne PW & majoriteten hær inne ser iallefall ikke noe rasjonelt med siste tids nedgang !!
3 Likes
Det innlegget har blitt sitert sikkert 20 ganger her inne, og er ikke noen fasit.
Du velger hva du tror på.
Men hvis du skal bruke henne som sannhetsvitne så får jeg minne om at hun beregnet studietid til 2.5 år og den er nå guidet til 3 år, så i henhold til hennes analyse så ble det 1 års utsettelse (6 måneder oppstart, 6 måneder lenger studie).
1 Like
and timelines for approval are in line with our base case scenario.
we believe the company has a very good change to hit the market in 2022.
1 Like
PCI Biotech: Prospectus approved
NOT FOR DISTRIBUTION OR RELEASE, DIRECTLY OR INDIRECTLY, TO UNITED STATES NEWS WIRE SERVICES OR FOR DISSEMINATION IN OR INTO THE UNITED STATES, AUSTRALIA, CANADA, JAPAN, HONG KONG OR SOUTH AFRICA, OR ANY OTHER JURISDICTION IN WHICH THE DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL. THIS ANNOUNCEMENT DOES NOT CONSTITUTE AN OFFER OF ANY OF THE SECURITIES DESCRIBED HEREIN.
Oslo, Norway, 17 September 2018. Reference is made to the Stock Exchange Notices published by PCI Biotech Holding ASA (“PCI Biotech” or the “Company”) on 24 August and 14 September 2018 regarding a guaranteed rights issue of 12 million new shares (the “Rights Issue”) at a subscription price of NOK 30 per new share.
The Financial Supervisory Authority of Norway (Nw. “Finanstilsynet”) has today approved the prospectus dated 17 September 2018 (the “Prospectus”) in connection with the Rights Issue.
The Prospectus will be published electronically on 19 September 2018 (at which date the subscription period commences), on the Company’s website (www.pcibiotech.com) and on the website of the Managers, ABG Sundal Collier ASA (www.abgsc.no) and Arctic Securities AS (www.arctic.com). A paper copy of the prospectus may then also be obtained, free of charge, at PCI Biotech Holding ASA, Ullernchausséen 64, NO-0379 Oslo and at ABG Sundal Collier ASA, Munkedamsveien 45E, NO-0115 Oslo, Norway and Arctic Securities AS, Haakon VII’s gate 5, NO-0123 Oslo, Norway.
Contact information:
Ronny Skuggedal, CFO, rs@pcibiotech.no, Mobile: +47 9400 5757
For more information visit: www.pcibiotech.com
Contact information: PCI Biotech Holding ASA, Ullernchausséen 64, Oslo, NO-0379Important Notice
The contents of this announcement have been prepared by, and are the sole responsibility of, the Company. The Company’s financial advisors are acting exclusively for the Company and no one else, and will not be responsible to anyone other than the Company for providing the protections afforded to their respective clients, or for advice in relation to the Rights Issue, the contents of this announcement or any of the matters referred to herein.The information in this announcement is for information purposes only and does not purport to be accurate or complete. No reliance may be placed for any purpose on the information contained in this announcement or its accuracy or completeness.
Matters discussed in this announcement may constitute forward-looking statements. Forward-looking statements are statements that are not historical facts and may be identified by words such as “believe”, “expect”, “anticipate”, “strategy”, “intends”, “estimate”, “will”, “may”, “continue”, “should” and similar expressions. The forward-looking statements in this release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that these assumptions were reasonable when made, these assumptions are inherently subject to significant known and unknown risks, uncertainties, contingencies and other important factors which are difficult or impossible to predict and are beyond its control. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this announcement by such forward-looking statements. The information, opinions and forward-looking statements contained in this announcement speak only as at its date, and are subject to change without notice. Neither the publication and/or delivery of this announcement shall under any circumstances imply that there has been no change in the affairs of the Company or that the information contained herein is correct as of any date subsequent to the earlier of the date hereof and any earlier specified date with respect to such information.
A prospectus approved by the competent authority in Norway is expected to be published by the Company before the Rights Issue commences (if and when made) and, if and when published, can be obtained on the Company’s website, subject to regulatory restrictions. Investors should not subscribe for any securities referred to in this announcement except on the basis of information contained in the prospectus.
Restrictions
Neither this announcement nor any copy of it may be made or transmitted directly or indirectly into the United States, Australia, Canada, Japan, Hong Kong or South Africa or any other jurisdiction where to do so would be unlawful. The Rights Issue (if made) and the distribution of this announcement and other information in connection with the Rights Issue may be restricted by law in certain jurisdictions. Any failure to comply with such restrictions may constitute a violation of applicable securities laws. Persons into whose possession this announcement or other information should come are required to inform themselves about and observe any such restrictions. The Company assumes no responsibility in the event there is a violation by any person of such restrictions.This announcement does not in itself constitute, and should not be construed as, an offer for sale or subscription of or solicitation or invitation of any offer to subscribe for or purchase any securities of the Company or its affiliates in any jurisdiction. The Rights Issue will (if and when made) not be made in any jurisdiction or in any circumstances in which such offer or solicitation would be unlawful. No steps have been taken or will be taken relating to the Rights Issue in any jurisdiction outside of Norway in which such steps would be required.
The securities referred to in this announcement have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), or any securities laws of any state or other jurisdiction of the United States and may not be offered or sold within the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and in compliance with applicable state law. There will be no public offer of the securities in the United States.
This announcement is only being distributed to and is only directed at persons in the United Kingdom that are (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the “Order”) or (ii) high net worth entities, and other persons to whom this announcement may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “relevant persons”). This announcement must not be acted on or relied on by persons who are not relevant persons. Any investment or investment activity to which this announcement relates is available only to relevant persons and will be engaged in only with relevant persons. Persons distributing this announcement must satisfy themselves that it is lawful to do so.
Further information regarding restrictions applicable for the Rights Issue will be set out in the prospectus prepared for the Rights Issue.
About PCI Biotech
PCI Biotech is a biopharmaceutical company focusing on development and commercialisation of novel therapies for the treatment of cancer through its innovative photochemical internalisation (PCI) technology platform. PCI is applied to three distinct anticancer paradigms: fimaCHEM (enhancement of chemotherapeutics for localised treatment of cancer), fimaVACC (T-cell induction technology for therapeutic vaccination), and fimaNAc (nucleic acid therapeutics delivery).Photochemical internalisation induces triggered endosomal release that is used to unlock the true potential of a wide array of therapeutic modalities. The Company’s lead fimaCHEM programme consists of a clinical Phase I/II clinical study in bile duct cancer, an orphan indication with a high unmet need and without approved products. fimaVACC applies a unique mode of action to enhance the essential cytotoxic effect of therapeutic cancer vaccines, which works in synergy with several other state-of-the-art vaccination technologies. fimaNAc utilises the endosomal release to provide intracellular delivery of nucleic acids, such as mRNA and RNAi therapeutics, thereby addressing one of the major bottlenecks facing this emerging and promising field.
This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.
Forward-looking statements
This announcement may contain forward-looking statements, which as such are not historical facts, but are based upon various assumptions, many of which are based, in turn, upon further assumptions. These assumptions are inherently subject to significant known and unknown risks, uncertainties and other important factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this announcement by such forward-looking statements. PCI Biotech disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Nyheten er levert av GlobeNewswire.
http://www.netfonds.no/quotes/release.php?id=20180917.GlobeNewswire.GNW1000099439-en
2 Likes
Denne var ny:
‘‘fimaVACC applies a unique mode of action to enhance the essential cytotoxic effect of therapeutic
cancer vaccines, which works in synergy with several other state-of-the-art vaccination technologies.’’
Her sier jo Pcib beint ut at fimaVACC gir synergieffekter i kombinasjon med state-of-the-art vaksiner. Blir vanvittig spennende å se dybdeanalysen fra dette studiet.
Noen som har en annen tolking av dette utsagnet? Når de velger å ordlegge seg på den måten så kan ikke jeg skjønne annet enn at de faktisk har sett positive effekter i fimaVACC studiet.
http://pcibiotech.no/rights-issue-approved-by-the-extraordinary-general-meeting-2/
15 Likes
Noe som er løgn. Fordi i sin analyse så hadde hun ett annet scenario som etter 9 måneders behandlingstid førte til at produktet kom på markedet rundt årsskiftet 2021/2022, men nå ser det ut som (hvis du forutsetter samme 9 måneder) at vi snakker årsskiftet 2022/2023. Muligens noen måneder før, men uansett 9 - 15 måneder senere enn hun forutsatte i sin analyse.
Men du velger selv hva du vil tro på. Jeg mener at hun er en dyktig analytiker, men at akkurat det innlegget er villedende.
1 Like
Prospektet tilgjengelig 19 sept. Blir interessant å lese.
Fimavacc!
3 Likes
Godt at jcp har den hele og fulle sannhet?
Lytte til de en vil men radforsk og Oslo cancer Cluster er uansett happy. Stuffers har også utdannelse og erfaring med biotek. Happy med det.
3 Likes
Er det en behandlingstid på søknad om AA på 9 mnd?
Trodde behandlingstiden var mye kortere hvis man har regulatoriske fordeler, mulig jeg har misforstått noe her.
Tar gjerne innspill! 
1 Like
Må være lov å si WOW!
Lukter gull! Men gjenstår å få dette presentert. Opsjon priset til 0 er uansett hyggelig?
1 Like
Jeg kan ingenting om teamet og syntes det virker lenge.
Men i sin rapport så har hun 9 måneder fra analysen er ferdig til produktet når markedet, ja. Det er mulig det skal tolkes til 6 måneders behandling hos myndigheter og 3 måneder fra godkjennelse til produktet når markedet, men totalen er i hvert fall 9 måneder.
1 Like
Nyenburgh og andre vil måtte streve hvis de skal kjøpe store poster om det kommer gode fimavacc resultater?
2 Likes
Dybdeanalysen fimavacc bør ut rimelig kjapt nå?
2 Likes
jeg heller mot checkpoint inhibitors 
og funker det blir FimaVacc Brennheit 
2nd generation immuno terapies checkpoint inhibitors have very good results but not good response rates.
FimaVacc is a potential technology to enhance the effect and response rates of the checkpoint inhibitors
4 Likes
Mulig det, men jeg tenkte mer på ordlyden JAXI.
Sånn jeg leser det så har de fått positiv respons på flere parametere. Noen andre som vil prøve seg med tolkning? Viser de bare til hva de har oppnådd pre-klinisk? Det er jo ingen forbehold her som ‘‘may’’, ‘‘might’’, ‘‘possible’’ etc.
Gjentar utsagnet en gang til:
‘’‘‘fimaVACC applies a unique mode of action to enhance the essential cytotoxic effect of therapeutic cancer vaccines, which works in synergy with several other state-of-the-art vaccination technologies.’’
Som sagt, de som klarer å tenke rasjonelt rundt denne emisjonen og har tørt krutt, kan fort gjøre tidenes kule om extension studiet og fimaVACC leverer på oppsiden.
Hva google translate sier om saken. Hadde en diskusjon med Glein på Nano tråden hvor han ble litt lost in translation, så kanskje greit å ta det på norsk også så det ikke blir noen misforståelser;)
‘’‘FimaVACC bruker en unik virkemåte for å forbedre den essensielle cytotoksiske effekten av terapeutiske kreftvacciner, som fungerer i synergi med flere andre toppmoderne vaksineringsteknologier’’
6 Likes
som jeg har sagt tidligere så kom det frem på Q1 den 08.mai at de nå begynnte med dennne dybdeanalysen.
Dybdeanalysen tar tid, og man kan regne 1 dag pr. “pasient” og studiet bestod av 90 personer. dvs at en slik analyse vil ta 90 arbeidsdager å fullføre.
September vil dette være 5mnd. siden dette arbeidet skulle påbegynnes og man skulle tro at man hadde kommet frem til ett resultat til da.
Så at de nå sitter på all dataen fra denne mener jeg er nærliggende og tro!
3 Likes
Om fimavacc viser positive resultater er det selvsagt hyggelig både for pasienter og aksjonærer (all den tid fimavacc og fimanac tillegges 0 verdi i dag analyser)!
2 Likes
Det har jo blitt sagt fra PCIB at resultater fra FimaVacc vil bli presentert på en konferanse. Ser vi på listen over konferanser de skal delta på er det jo mest opplagt at det blir denne, ESMO Immuno-Oncology Congress, Geniva. Den foregår 13-16 desember.
Jeg tror at vi får resultatene her og jeg tror de kommer til å være meget gode. For dem som ikke klarer å vente på dem er det jo bare å selge seg ut nå og kjøpe igjen i starten av desember
3 Likes
Per Walday sa ved Q&A ved Q1 at de i tillegg til å presentere dataene ved en konferanse, også vil oppdatere markedet når de er klare med data. Tror han brukte uttrykket at de vil presentere dem “on a high level”, altså overordnet nivå.
Så det er all grunn til å vente en oppdatering på dette før ESMO 13-16 desember.
6 Likes